Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZEN1033IL/27
Study information
Scientific title
A Randomised Double-Blind, Double Dummy Trial to Compare the Efficacy and Safety of Arimidex with Tamoxifen as First line Therapy for Advanced Breast Cancer in Post-Menopausal Women
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised Double-Blind Double Dummy Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Breast cancer
Intervention
1. Group A: Arimidex (anastrozole) 1 mg plus tamoxifen placebo daily
2. Group B: Tamoxifen 20 mg plus Arimidex placebo daily
Intervention type
Drug
Phase
Not Specified
Drug names
Arimidex with Tamoxifen
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
01/07/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with locally advanced or metastatic breast cancer who are candidates to receive hormonal therapy as first line therapy for advanced disease (patients may have received adjuvant chemotherapy or hormonal therapy but patients who have received tamoxifen as adjuvant therapy must have an interval of at least 12 months since stopping tamoxifen and entry into this trial)
2. Post-menopausal defined as:
2.1 Aged >50 years or who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone (FSH) levels within the post-menopausal range
2.2 Women aged <50 years who have FSH levels within the post-menopausal range
3. Hormone receptor (oestrogen receptor and or progesterone receptor) positive or unknown
4. Measurable or evaluable disease
5. No previous systemic therapy for advanced breast cancer
6. No drug-maintained menopausal status
7. No evidence of life threatening visceral disease
8. Life expectancy of >3 months
9. No treatment with a non-approved or experimental drug within the preceding 3 months before randomisation
10. No prior history of other malignancy other than breast cancer, except basal cell or squamous cell carcinoma of the skin or cancer of the cervix which has been satisfactorily controlled
11. No contraindications to protocol treatments
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
01/07/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list